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Ulcerative Colitis in RemissionPhase 4STOPNCT07718529

Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis

A Phase 4 study testing treatment withdrawal in people with Ulcerative Colitis in Remission, run by Assistance Publique Hopitaux De Marseille at 22 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This phase IV, multicenter, open-label randomized controlled trial will evaluate whether a JAK inhibitor discontinuation strategy is superior to standard maintenance therapy in adult patients with ulcerative colitis who are in sustained deep remission. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis in Remission
What is being tested?
treatment withdrawal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
22 sitesFrance
Study dates
Jan 2027to Jan 2031
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of UC from at least 6 months according to clinical, endoscopic, histological and/or radiological criteria.
  • Male or female age ≥ 18 years
  • Currently treated by JAK inhibitor (tofacitinib, upadacitinib or filgotinib) for more than 12 months.
  • Currently at a stable dose of tofacitinib (5mg or 10mg twice a day), upadacitinib (15mg or 30mg per day) or filgotinib (200mg per day) for 6 months.
  • Clinical steroid free remission for at least 6 months, defined by a partial Mayo Score < 2, with no subscore > 1 and rectal bleeding (RB) subscore of 0 (annex 1).
  • Endoscopic steroid free remission for at inclusion, defined by a Mayo endoscopic subscore = 0 (annex 1).
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  • Fecal calprotectin ≤ 150μg/g.
  • Without known risk factors for venous thromboembolism (VTE).
  • Without known risk factors for major adverse cardiovascular events (MACE).
  • Without known risk factors for malignancy.
  • For women of child-bearing potential (WOCBP), and for men with partners who are WOCBP, willingness to use appropriate and efficient contraception, as recommended when using JAK inhibitor treatment (notably upadacitinib), during all the experimental treatment and until at least 4 weeks after the end of the experimental treatment, according to SmPC and CTFG (Clinical Trials Facilitation and Coordination Group) recommendations.
  • Patients able to understand information provide to them and to give written informed consent for study.
  • Affiliation to a social security scheme.
  • Good general health according to history and clinical examination.

Who cannot join

  • Steroid use ≤ 6 months prior to enrolment.
  • Currently treated by steroid, immunosuppressive agents or biologics.
  • Pregnancy or planned pregnancy during the study.
  • Breastfeeding.
  • Non-compliant subject or inability to follow study protocol.
  • Intolerance of JAK inhibitors (excipients included) or severe adverse event.
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  • Contraindications to using a JAK inhibitor (excipients included).
  • Known risk factors for VTE.
  • Known risk factors for MACE.
  • Active neoplasia or history of malignant tumours less than 5 years old.
  • Participation to another interventional study protocol (except for RIPH3 studies)
  • Severe hepatic insufficiency.
  • Severe to end-stage renal insufficiency.
  • Active tuberculosis, serious infections such as septicemia or opportunistic infections.
  • Absence or refusal of informed consent.
  • People under guardianship, conservatorship, or judicial protection;
  • People receiving psychiatric care;
  • People who have been deprived of their liberty by judicial or administrative order
  • People with difficulty understanding and/or cognitive disorder

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Amandine ROLLAND-BRUN contact

+33 04 91 38 12 45 ext. +33

amandine.rolland@ap-hm.fr

22 sites in 1 country

France22 sites

  • CHU Amiens-Picardie

    Amiens

    Mathurin Fumery, +330322088849, fumery.mathurin@chu-amiens.fr

    Mathurin FUMERY

  • Centre Hospitalier d'Avignon

    Avignon

    Alban Benezech, +330432753409, benezech.alban@ch-avignon.fr

    Alban BENEZECH

  • CHRU Besançon

    Besançon

    Lucine Vuitton, +330381218683, lvuitton@chu-besancon.fr

    Lucine VUITTON

  • CHU Bordeaux

    Bordeaux

    pauline rivière, +330557656094, pauline.riviere@chu-bordeaux.fr

    Pauline RIVIERE

  • CHU Clermont Ferrand

    Clermont-Ferrand

    Anthony Buisson, +330473750598, a_buisson@chu-clermontferrand.fr

    Anthony BUISSON

  • Chu Lille

    Lille

    Maria Nachury, +330320444714, maria.nachury@chru-lille.fr

    Maria NACHURY

  • HCL

    Lyon

  • AP-HM hopital Nord

    Marseille

    Lucas GUILLO, +330491968737, lucas.guillo@ap-hm.fr

    Lucas GUILLO

  • CHU Montpellier

    Montpellier

    Romain Altwegg, +330467337064, r-altwegg@chu-montpellier.fr

    Romain ALTWEGG

  • CHRU Nancy

    Nancy

    Bénédicte Caron, b.caron@chru-nancy.fr

    Benedicte CARON

  • CHU Nantes

    Nantes

    Arnaud Bourreille, +330240083152, arnaud.bourreille@chu-nantes.fr

    Arnaud BOUREILLE

  • CHU Nice

    Nice

    Adrien Nicolau, +330492036168, nicolau.a@chu-nice.fr

    Adrien NICOLAU

  • CHU Nîmes

    Nîmes

    Ludovic Caillo, +330466683183, Ludovic.CAILLO@chu-nimes.fr

    Ludovic CAILLO

  • Hôpital Beaujon

    Paris

    Alexandre Nuzzo, +330140875668, alexandre.nuzzo@aphp.fr

    Alexandre NUZZO

  • Hôpital Bicêtre

    Paris

    Aurélien Amiot, +330145213726, aurelien.amiot@aphp.fr

    Aurélien AMIOT

  • Hôpital Henri-Mondor

    Paris

    Mathieu Uzzan, +330149812362, mathieu.uzzan@aphp.fr

    Mathieu UZZAN

  • Institut des MICI

    Paris

    Carmen Stefanescu, +330141430573, carmen.stefanescu@institutdesmici.fr

    Carmen STEFANESCU

  • Chu Rennes

    Rennes

    Guillaume Bouguen, +330299284347, Guillaume.BOUGUEN@chu-rennes.fr

    Guillaume BOUGUEN

  • CHU Rouen

    Rouen

    Nicolas Richard, +330232886634, nicolas.richard@chu-rouen.fr

    Nicolas RICHARD

  • CHU St Etienne

    Saint-Etienne

    Xavier Roblin, +330477828119, xavier.roblin@chu-st-etienne.fr

    Xavier ROBLIN

  • Chits Toulon

    Toulon

    Camille Silbertin Blanc, +330494144163, camille.sibertin-blanc@ch-toulon.fr

    Camille SIBERTIN BLANC

  • CHU Toulouse

    Toulouse

    Cyrielle Gilletta, +330561323080, Gilletta.c@chu-Toulouse.fr

    Cyrielle GILETTA

Other trials in France

About this study

Official title: Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis: a Randomized Controlled Trial

This phase IV, multicenter, open-label randomized controlled trial will evaluate whether a JAK inhibitor discontinuation strategy is superior to standard maintenance therapy in adult patients with ulcerative colitis who are in sustained deep remission. A total of 224 patients treated with tofacitinib, upadacitinib, or filgotinib will be randomized to either treatment withdrawal or continuation of maintenance therapy and followed for 104 weeks. The primary objective is to compare safety, efficacy, and patient satisfaction at Week 52, while secondary objectives include assessment of remission maintenance, quality of life, treatment exposure, endoscopic outcomes, and relapse rates

Read the detailed description

Background:

Janus kinase (JAK) inhibitors are effective oral therapies for moderate-to-severe ulcerative colitis (UC). Their lack of immunogenicity provides a unique opportunity to evaluate treatment withdrawal and intermittent treatment strategies. However, safety concerns raised by regulatory agencies, including increased risks of infections, venous thromboembolism, major adverse cardiovascular events, and malignancies, support the investigation of strategies aiming to reduce long-term exposure to JAK inhibitors while maintaining disease control.

Objective:

To demonstrate the superiority of a JAK inhibitor stopping strategy compared with standard maintenance therapy in terms of treatment safety, efficacy, and patient satisfaction in adults with ulcerative colitis in deep remission.

Study Design:

This is a phase IV, prospective, multicenter, open-label, randomized controlled trial. Adult patients with ulcerative colitis receiving a stable dose of tofacitinib, upadacitinib, or filgotinib for at least 12 months and achieving sustained steroid-free clinical, biological, and endoscopic remission for at least 6 months will be randomized to either treatment discontinuation or continuation of standard maintenance therapy. A total of 224 participants will be enrolled and followed for 104 weeks.

Primary Endpoint:

The primary endpoint is a composite outcome assessing treatment safety, efficacy, and patient satisfaction during the first 52 weeks after randomization. Patient satisfaction will be evaluated using the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4).

Secondary Endpoints:

Secondary outcomes include adverse events and serious adverse events, maintenance of remission, treatment satisfaction, quality of life, JAK inhibitor exposure, endoscopic outcomes, relapse rates, treatment success at Weeks 52 and 104, and identification of predictors of successful treatment discontinuation.

Expected Benefits:

Reducing exposure to JAK inhibitors may improve the overall safety profile by decreasing treatment-related adverse events while reducing treatment burden for patients with ulcerative colitis. This strategy could support a more individualized and potentially safer long-term management approach for patients in sustained deep remission.

Being tested
treatment withdrawal
Keywords
ulcerative colitis, treatment removal
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • treatment withdrawalDrug

    the patients will stop their treatment, as long as possible until symptom reappearance, if any

Study groups in NCT07718529
Study groupRoleWhat they receive
standard of careNo interventionNot described
STOP, treatment withdrawalExperimentalNot described
Receives: Drug: treatment withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.

    treatment safety, during the first 52 weeks of the follow-up.

    Measured: 1 year

  2. The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.

    treatment efficacy, during the first 52 weeks of the follow-up.

    Measured: 1 year

  3. The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.

    patient satisfaction during the first 52 weeks of the follow-up.

    Measured: 1 year

Secondary outcomes (8)

  1. Safety: occurrence of herpes zoster, infection, cardiovascular event, biochemical parameter, malignancies, adverse event leading to discontinuation, and all adverse events (serious or not) during the whole follow-up.

    Measured: 2 years

  2. Remission rate at the end the first 52 weeks of the follow-up

    Measured: 1 year

  3. Assess the treatment success of this innovative therapeutic strategy at the end of the first 52 weeks of the follow-up and after 104 weeks of follow-up.

    Measured: 2 years

  4. Partial Mayo score at each visit of the entire follow-up

    Measured: 2 years

  5. Number of days under treatment and cumulative dose of treatment per patient between randomization and primary endpoint

    Measured: 1 year

  6. Number of days under induction dose of JAK inhibitor at the end the first 52 weeks of the follow-up.

    Measured: 1 year

  7. Mayo endoscopic subscore at week 52 and week 104

    Measured: 2 years

  8. Proportion of patients relapsing for each arm

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07718529
Sponsor's protocol ID
RCAPHM24_0353 - STOP
Other IDs
2026-525643-32-00
Acronym
STOP
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing treatment withdrawal in people with Ulcerative Colitis in Remission, run by Assistance Publique Hopitaux De Marseille at 22 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amandine ROLLAND-BRUN (+33 04 91 38 12 45 ext. +33, amandine.rolland@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07718529.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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